# K240293: STS

- Pathway: 510(k) (Traditional)
- Applicant: Techbopulm, Ltd.
- Decided: Sep 17, 2024 after 229 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K013812 (2002). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161295: MiniBox +, Pulmone Advanced Medical Devices, Ltd. (2016) Summary page 5.

## Indications for use
The STS device is intended to measure lung function in adult patients while at rest (including spirometry and lung volumes). The STS device is to be used by either a physician, respiratory therapist, or technician. The STS device is intended to be used in a professional healthcare environment.

Source page: https://510kreport.com/device/K240293
Methodology: https://510kreport.com/methodology